- Insmed Incorporated (Bridgewater, NJ)
- …identified by risk assessment and Monitoring and Auditing teamCollaborate with Compliance Operations to support system and/or process enhancements to support ... fun? Yes? Then maybe you will be our next Manager of US Compliance ! This role will...biotech company.High level of familiarity with broad range of compliance risk areas, in particular relating to… more
- Merck & Co. (Durham, NC)
- …and warehouse.--As the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global ... and ultimately shop floor leadership.-Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... (IR) and pre-approval Inspection preparation activities for global clinical operations , responsible for representing the GCO-CQM inspection readiness within the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project team level and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead and study team ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Eisai, Inc (Nutley, NJ)
- …other relevant security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue ... recovery testing.Regularly review adherence to standards.Oversee regional security vendors.Prioritize risk -based reduction efforts. Manager investigations.General Compliance … more
- Aequor (Bothell, WA)
- …Eight (8) or more years of relevant work experience in pharmaceutical quality operations , quality assurance, quality systems, and/or IT compliance role with at ... team members in a matrixed environment. Demonstrated experience utilizing Risk Management tools (eg FMEA, FTA tools) to understand...and change management of e-systems used across the site operations are conducted in compliance with applicable… more
- Merck & Co. (North Wales, PA)
- …Strategy, Innovations and Operations and assigned team, the Medical Affairs Project Manager (MA PM) will provide project management support for a variety of USMA ... and provide project updates/summariesNavigate internal processes and procedures, including compliance and finance, to ensure compliant execution of assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work environment Builds strong partnerships with HR Business Partners, Employment Law, Compliance , Risk and Accountability, and all internal partners to foster ... NJ facility and follows a hybrid work schedule. The Position The Manager , Employee Relations role ensures consistent and thorough management of Employee Relations… more
- Catalent (TX)
- Job Description Manager , Contract Management The Manager , Contract Management serves as a strategic business partner to our Business Development and Legal ... organizations. The Manager , Contract Management will support the development and execution...leads to achieve timely deal closure and growth expectations.Mitigates risk through understanding of proposed terms and conditions and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with global… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …the Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance , will oversee end-to-end contract ... management for the Institute and manage daily operations for all federal contracts and compliance ... of the Office of Research Contracts (ORC).The Contracts Manager - Federal Contracts and Compliance will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, ... in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Financial Disbursements, that manages the day-to-day Financial Disbursement operations (Accounts Payable Processing, Travel and Expense Reimbursement and ... and accuracy of payments. Specifically, this role will be accountable for operations , suggest and collaborate with Financial Disbursement team members and global… more
- Tris Pharma (Monmouth Junction, NJ)
- …Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures ... New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ,...systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Insmed Incorporated (Bridgewater, NJ)
- …purchase orders and inventory movements are managed, documented and administered in compliance with the company procedures and policies. The Planner must be ... supply chain performance goals.Support budgeting cycleSupport monthly Sales & Operations Planning process and other supply related meetingsInventory ManagementPerform… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working ... skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership, Direction, and Strategy:Establishes Data Management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy ... leadership, across all organizations within CMR as well as Procurement, Legal, Compliance , Privacy and other key focus areas. To support the successful planning… more
